Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine.
- Author:
Wen-ke ZHENG
;
Zhi LIU
;
Xiang LEI
;
Ran TIAN
;
Rui ZHENG
;
Nan LI
;
Jing-tian REN
;
Xiao-xi DU
;
Hong-cai SHANG
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic;
Drug-Related Side Effects and Adverse Reactions;
epidemiology;
etiology;
Drugs, Chinese Herbal;
adverse effects;
chemistry;
economics;
therapeutic use;
Herbal Medicine;
economics;
legislation & jurisprudence;
Humans;
Patents as Topic;
Product Surveillance, Postmarketing;
Quality Control
- From:
China Journal of Chinese Materia Medica
2015;40(18):3693-3696
- CountryChina
- Language:Chinese
-
Abstract:
The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.
